FDA Approves J&J's Rybrevant Faspro for Head and Neck Cancer
NEW BRUNSWICK, N.J. – November 06, 2026 -- The U.S. Food and Drug Administration has granted accelerated approval to Johnson & Johnson's RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), backed by a confirmed 42 percent overall response rate in a 102-patient cohort.
Approval covers post-platinum, post-immunotherapy patients and excludes HPV-associated oropharyngeal disease
The subcutaneous single-agent therapy is cleared for adults whose disease progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The indication excludes patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC). J&J says it is the first dual-targeted therapy approved in this setting, hitting both EGFR and MET, and describes it as the first advance in second-line treatment of the disease in a decade.